Sensor kits for sleep diagnostic testing

ABSTRACT

System for storing pre-packaged sleep related sensors and facilitating effective, efficient, or error-free usage of the sleep related sensors for sleep diagnostic testing including a thoracic respiratory effort belt, an abdominal effort belt, an oxygen saturation sensor, and a nasal and oral airflow sensor, a receptacle for storing sleep-related sensors, and instruction for using the sleep-related sensors.

CLAIM OF PRIORITY

This patent application claims the benefit of priority to U.S.Provisional Patent Application Ser. No. 61/092,448, filed on Aug. 28,2008, which application is herein incorporated by reference in itsentirety.

TECHNICAL FIELD

The present subject matter relates generally to the field ofneurological disorders and more specifically to the area of sleepmedicine and yet even more specifically to the area of sleep diagnosisfor patients who suffer from sleep disorders. More particularly, thepresent subject matter relates to sensor kits for sleep diagnostictesting.

BACKGROUND

Sleep disorders have recently become the focus of a growing number ofphysicians. Sleep disorders include obstructive sleep apnea, centralsleep apnea, complex sleep apnea, snoring, restless leg syndrome (RLS),periodic limb movement (PLM), sudden infant death syndrome (SIDS), andrelated neurological and physiological events or conditions occurringduring sleep. Many hospitals and clinics have established sleeplaboratories (sleep labs) to diagnose and treat sleep disorders. In thesleep laboratories, practitioners use instrumentation to monitor andrecord a patient's sleep states, stages and behaviors during sleep.Practitioners rely on these recordings to diagnose patients andprescribe proper therapies.

A goal of addressing sleeping disorders is to help a person sleepbetter. Another goal of addressing sleeping disorders is to help aperson live longer. It is well known that various undesirable behaviorsoften occur during sleep such as snoring, apnea episodes, abnormalbreathing episodes, Bruxism (teeth clenching and grinding) and the like.It is further known that these disorders and other undesirable behaviorscan not only lead to insufficient amounts of sleep or fatigue but arealso linked to co-morbidities such as obesity, diabetes, cardiacdiseases, stroke and SIDS, all of which lead to a premature death.Serious efforts are being made to reduce or eliminate these undesirabledisorders and behaviors in part because of these co-morbidity concerns.

SUMMARY

The present subject matter provides a means for a clean and convenientmethod to use a pre-arranged and pre-packaged, disposable or reusablesensor kit for the home or the sleep laboratory setting.

Historically, sleep studies have been done in sleep labs or sleepclinics. There has been a predisposition to using reusable sensorbecause of the cost factor. Some labs have decided to use disposablesensors because of infection control and the ease of no cleaning betweentests.

Efforts continue to use home testing or at least home screening insteadof making the patient come in to a sleep lab facility for an overnightstudy. There are many good reasons for home studies. First, it is lessexpensive in that hospital costs are avoided. Secondly, it is easier toget patients to agree to get a study done in their own homes and manypatients are unable, for one reason or another, to come to the clinic orlab.

It is believed that clinic and patients will be receptive to usingdisposable sensors for home studies. Use of disposable sensors andelectrodes relieve patient concerns about reusable sensors andelectrodes, including concerns of who may have used the sensors andelectrodes last, or who may have cleaned them, and how well they werecleaned.

It has been determined by the American Academy of Sleep Medicine (AASM)that there will be four different levels of portable home studies. Eachmay require a different suite of equipment that will record differentkinds of data to be evaluated and each of the four levels will requiredifferent electrodes/sensors. Level I is the most detailed and isidentical to what is done in a hospital or clinic sleep center with avariety of polysomnograph (PSG) machines. Levels II, III and IV requirerecording less and less data in descending order.

Level I or Type I testing is what is generally accepted as an attendedstandard polysomnography (PSG) test with a minimum of seven parametersobserved and measured, including:

-   -   1. Electrooculogram (EOG)    -   2. Electroencephalogram (EEG)    -   3. Electrocardiogram (ECG)    -   4. Electromyogram (EMG)    -   5. Airflow    -   6. Respiratory Effort    -   7. Oxygen Saturation

In certain examples, a sleep practitioner/technician is required to bein constant attendance during testing.

Level II or Type II testing is referred to as testing with devices thatare comprehensive and portable and that measure the same channels asType I testing, except that a heart-rate monitor may replace theelectrocardiogram and a sleep practitioner is not necessarily inconstant attendance.

Level III or Type III testing encompasses devices that have a minimum offour sensor channels monitored, including ventilation or airflow (atleast two channels of respiratory movement, or respiratory movement andairflow), heart rate or ECG, and oxygen saturation.

Level IV or Type IV testing involves testing with devices thatcontinuously monitor one or two parameters, typically airflow and oroxygen saturation.

Applicants have devised specialized disposable kits loaded with thesensors and electrodes each patient will need for the home study foreach level of testing or screening the patient will be doing. It isexpected that the technician conducting the test will provide thenon-disposable electronic equipment, such as the ECG machine, the pulseoxymeter, the EEG machine and the electronic fetal monitoring (EFM)machine that may be required for each study.

A feature of the present subject matter includes providing disposablecomponents that comes in contact with the patient, e.g., the sensors andelectrodes.

There is a need to provide a sleep practitioner with a variety of TypeI, Type II, Type III and Type IV sensor kits that contain sleep relatedsensors that are pre-packaged in a sterile, compartmental tray or sealedpouch with appropriate ID markings to facilitate error-free usage.

There is a need to provide a sleep practitioner with a variety of TypeI, Type II, Type III and Type IV sensor kits that contains sleep relatedsensors/electrodes that are pre-arranged.

There is a need to provide a sleep practitioner with a variety of TypeI, Type II, Type III and Type IV sensor kits that contains sleep relatedsensors/electrodes that are clean, new and unused.

There is a need to provide a sleep practitioner with a variety of TypeI, Type II, Type III and Type IV sensor kits that contains sleep relatedsensors/electrodes that are sterile.

There is a need to provide a sleep practitioner with a variety of TypeI, Type II, Type III and Type IV sensor kits that contains sleep relatedsensors/electrodes that are reusable.

There is a need to provide a sleep practitioner with a variety of TypeI, Type II, Type III and Type IV sensor kits that contain a multitude ofvarious connector terminations to interface with the differentcommercially available PSG type devices that are presently used in sleeplaboratories and that may also be used for home testing.

There is also a need to provide a sleep practitioner with a variety ofType I, Type II, Type III and Type IV sensor kits that contain sleeprelated sensors/electrodes that are disposable rather than reusable.

Certain embodiments of the present invention provide a sensor kit forhome sleep diagnostic testing that by means of being pre-packaged andbeing pre-arranged in a compartmentalized tray or sealed pouch toprovide the clinical sleep practitioner and the home sleep patient witha clean, safe and convenient means of providing a complete sensor kitfor the appropriate level of sleep testing being prescribed.

In one embodiment, a sensor kit for a Type I sleep diagnostic testingincluded a thoracic (chest) effort belt, an abdominal effort belt, anoxygen saturation sensor, a nasal and oral airflow sensor, ECGelectrodes, bipolar surface EMG electrodes, a triple EMG chin electrode,three EOG/ground electrodes, ten EEG electrodes and one neck snoresensor.

In another embodiment, a sensor kit for Type II sleep diagnostic testingincludes a thoracic (chest) effort belt, an abdominal effort belt, anoxygen saturation sensor, a nasal and oral airflow sensor, ECGelectrodes, a set of bipolar surface EMG electrodes, a triple EMG chinelectrode, and set of three EOG/ground electrodes.

In another embodiment, a sensor kit for Type III sleep diagnostictesting includes a thoracic (chest) effort belt, an abdominal effortbelt, an oxygen saturation sensor, a nasal and oral airflow sensor and aset of two ECG electrodes. In another embodiment, a sensor kit for TypeIV sleep diagnostic testing includes only a thoracic (chest) effortbelt, an abdominal effort belt, an oxygen saturation sensor and a nasaland oral airflow sensor.

In an example, a sensor kit is provided for diagnostic testingconsisting of a compartmentalized tray or seal pouch and a multitude ofsensors/electrodes that are used during sleep diagnostic testing. Thekit may include a thoracic (chest) effort belt, an abdominal effortbelt, an oxygen saturation sensor, a nasal and oral airflow sensor, ECGelectrodes, a bipolar surface EMG electrode, a triple EMG chinelectrode, three EOG/ground electrodes, ten EEG electrodes and one necksnore sensor, each type of device being stored in a differentcompartment of the tray or sealed pouch and optionally labeled toidentify the electronic equipment each is to be used with.

In Example 1, a system for storing pre-packaged sleep related sensorsand facilitating effective, efficient, or error-free usage of thesleep-related sensors for sleep diagnostic testing, the system includinga receptacle configured to store sleep related sensors and a single setof sleep-related sensors. The single set of sleep-related sensorsincluding a thoracic respiratory effort belt configured to detect chestmovement indicative of respiratory effort, an abdominal respiratoryeffort belt configured to detect abdominal movement indicative ofrespiratory effort, an oxygen saturation sensor configured to anindication of blood oxygen saturation, and a nasal and oral airflowsensor configured to detect nasal and oral air flow information, whereinthe receptacle includes instructions for using the thoracic respiratoryeffort belt, the abdominal effort belt, the oxygen saturation sensor,and the nasal and oral airflow sensor for sleep diagnostic testing.

In example 2, the single set of sleep-related sensors of Example 1optionally includes a set of electrocardiogram (ECG) electrodesconfigured to sense electrical signals indicative of cardiac activity,and the receptacle of Example 1 optionally includes instructions forusing the set of ECG electrodes for sleep diagnostic testing.

In Example 3, the single set of sleep-related sensors of any of Examples1-2 optionally includes a set of electrocardiogram (ECG) electrodesconfigured to sense electrical signals indicative of cardiac activity, aset of bipolar surface electromyogram (EMG) electrodes configured todetect an indication of electrical activity of a muscle, and a tripleEMG chin electrode configured to detect an indication of electricalactivity at or near a chin, and the receptacle of any of Example 1-2optionally includes instructions for using the set of EMG electrodes,the triple EMG chin electrode, and the set of EOG electrodes for sleepdiagnostic testing.

In Example 4, the single set of sleep-related sensors of any of Examples1-3 optionally includes a set of electroencephalogram (EEG) electrodesand the receptacle of any of Examples 1-3 optionally includesinstructions for using the set of EEG electrodes for sleep diagnostictesting.

In example 5, the single set of sleep-related sensors of Example 1consisting of the thoracic respiratory effort belt configured to detectchest movement indicative of respiratory effort, the abdominalrespiratory effort belt configured to detect abdominal movementindicative of respiratory effort, the oxygen saturation sensorconfigured to an indication of blood oxygen saturation, and the nasaland oral airflow sensor configured to detect nasal and oral air flowinformation.

In Example 6, the single set of sleep-related sensors of Example 1consisting of the thoracic respiratory effort belt configured to detectchest movement indicative of respiratory effort, the abdominalrespiratory effort belt configured to detect abdominal movementindicative of respiratory effort, the oxygen saturation sensorconfigured to an indication of blood oxygen saturation, the nasal andoral airflow sensor configured to detect nasal and oral air flowinformation, and a set of electrocardiogram (ECG) electrodes configuredto sense electrical signals indicative of cardiac activity, and thereceptacle of Example 1 includes instructions for using the set of ECGelectrodes for sleep diagnostic testing.

In Example 7, the single set of sleep-related sensors of Example 1consisting of the thoracic respiratory effort belt configured to detectchest movement indicative of respiratory effort, the abdominalrespiratory effort belt configured to detect abdominal movementindicative of respiratory effort, the oxygen saturation sensorconfigured to an indication of blood oxygen saturation, the nasal andoral airflow sensor configured to detect nasal and oral air flowinformation, a set of electrocardiogram (ECG) electrodes configured tosense electrical signals indicative of cardiac activity, a set ofbipolar surface electromyogram (EMG) electrodes configured to detect anindication of electrical activity of a muscle, a triple EMG chinelectrode configured to detect an indication of electrical activity ator near a chin, and a set of electrooculogram (EOG) electrodesconfigured to detect an indication of eye movement, and the receptacleof Example 1 includes instructions for using the set of ECG electrodesconfigured to detect an indication of electrical brain activity, the setof EMG electrodes, the triple EMG chin electrode, and the set of EOGelectrodes for sleep diagnostic testing.

In Example 8, the single set of sleep-related sensors of Example 1consisting of the thoracic respiratory effort belt configured to detectchest movement indicative of respiratory effort, the abdominalrespiratory effort belt configured to detect abdominal movementindicative of respiratory effort, the oxygen saturation sensorconfigured to an indication of blood oxygen saturation, the nasal andoral airflow sensor configured to detect nasal and oral air flowinformation, a set of electrocardiogram (ECG) electrodes configured tosense electrical signals indicative of cardiac activity, a set ofbipolar surface electromyogram (EMG) electrodes configured to detect anindication of electrical activity of a muscle, a triple EMG chinelectrode configured to detect an indication of electrical activity ator near a chin, a set of electrooculogram (EOG) electrodes configured todetect an indication of eye movement, and a set of electroencephalogram(EEG) electrodes configured to detect an indication of electrical brainactivity, and the receptacle of example 1 includes instructions forusing the set of ECG electrodes, the set of EMG electrodes, the tripleEMG chin electrode, the set of EOG electrodes, and the set ofelectroencephalogram (EEG) electrodes for sleep diagnostic testing.

In Example 9, the receptacle of any of Examples 1-8 optionally includesa pouch.

In Example 10, the receptacle of any of Examples 1-8 includes acompartmentalized tray.

In Example 11, a method for storing pre-packaged sleep related sensorsto facilitate effective, efficient, or error-free usage of the sleeprelated sensors for sleep diagnostic testing includes storing a singleset of sleep-related sensors in a receptacle and providing instructionswith the receptacle for using the thoracic respiratory effort belt, theabdominal respiratory effort belt, the oxygen saturation sensor, and thenasal and oral airflow sensor. The step of storing the single set ofsleep-related sensors includes storing a thoracic respiratory effortbelt configured to detect chest movement indicative of respiratoryeffort, storing an abdominal respiratory effort belt configured todetect abdominal movement indicative of respiratory effort, storing anoxygen saturation sensor configured to an indication of blood oxygensaturation, and storing a nasal and oral airflow sensor configured todetect nasal and oral air flow information.

In Example 12, the storing the single set of sleep-related sensors inthe receptacle of Example 11 optionally includes storing a set ofelectrocardiogram (ECG) electrodes configured to detect an indication ofcardiac activity, and the method of Example 11 optionally includesproviding instructions with the receptacle for using the ECG electrodesfor sleep diagnostic testing.

In Example 13, the storing the single set of sleep-related sensors inthe receptacle of any Examples of 11-12 optionally includes storing aset of bipolar surface electromyogram (EMG) electrodes configured todetect an indication of electrical activity of a muscle, storing atriple EMG chin electrode configured to detect an indication ofelectrical activity at or near a chin, and storing a set ofelectrooculogram (EOG) electrodes configured to detect an indication ofeye movement, and the method of any of examples 11-12 optionallyincludes providing instructions with the receptacle for using the set ofbipolar surface EMG electrodes, the triple EMG chin electrode, and theset of EOG electrodes for sleep diagnostic testing.

In Example 14, the storing the single set of sleep-related sensors inthe receptacle of any of Examples 11-13 optionally includes storing aset of electroencephalogram (EEG) electrodes configured to detect anindication of electrical brain activity, and the method of any ofExamples 11-13 optionally includes providing instructions for using theset of EEG electrodes for sleep diagnostic testing.

In Example 15, the storing the single set of sleep-related sensors inthe receptacle of Example 11 consists of storing the thoracicrespiratory effort belt configured to detect chest movement indicativeof respiratory effort, storing the abdominal respiratory effort beltconfigured to detect abdominal movement indicative of respiratoryeffort, storing the oxygen saturation sensor configured to an indicationof blood oxygen saturation, and storing the nasal and oral airflowsensor configured to detect nasal and oral air flow information.

In Example 16, the storing the single set of sleep-related sensors inthe receptacle of Example 11 consists of storing the thoracicrespiratory effort belt configured to detect chest movement indicativeof respiratory effort, storing the abdominal respiratory effort beltconfigured to detect abdominal movement indicative of respiratoryeffort, storing the oxygen saturation sensor configured to an indicationof blood oxygen saturation, storing the nasal and oral airflow sensorconfigured to detect nasal and oral air flow information, and storing aset of ECG electrodes configured to detect an indication of cardiacactivity, and the method of Example 11 includes providing instructionswith the receptacle for using the ECG electrodes for sleep diagnostictesting.

In Example 17, the storing the single set of sleep-related sensors inthe receptacle of Example 11 consists of storing the thoracicrespiratory effort belt configured to detect chest movement indicativeof respiratory effort, storing the abdominal respiratory effort beltconfigured to detect abdominal movement indicative of respiratoryeffort, storing the oxygen saturation sensor configured to an indicationof blood oxygen saturation, storing the nasal and oral airflow sensorconfigured to detect nasal and oral air flow information, and storing aset of ECG electrodes configured to detect an indication of cardiacactivity, storing a set of bipolar surface electromyogram (EMG)electrodes configured to detect an indication of electrical activity ofa muscle, storing a triple EMG chin electrode configured to detect anindication of electrical activity at or near a chin, and storing a setof electrooculogram (EOG) electrodes configured to detect an indicationof eye movement, and the method of Example 11 includes providinginstructions with the receptacle for using the ECG electrodes, the setof bipolar surface EMG electrodes, the triple EMG chin electrode, andthe set of EOG electrodes for sleep diagnostic testing.

In Example 18, the storing the single set of sleep-related sensors inthe receptacle of Example 11 consists of storing the thoracicrespiratory effort belt configured to detect chest movement indicativeof respiratory effort, storing the abdominal respiratory effort beltconfigured to detect abdominal movement indicative of respiratoryeffort, storing the oxygen saturation sensor configured to an indicationof blood oxygen saturation, storing the nasal and oral airflow sensorconfigured to detect nasal and oral air flow information, and storing aset of ECG electrodes configured to detect an indication of cardiacactivity, storing a set of bipolar surface electromyogram (EMG)electrodes configured to detect an indication of electrical activity ofa muscle, storing a triple EMG chin electrode configured to detect anindication of electrical activity at or near a chin, storing a set ofelectrooculogram (EOG) electrodes configured to detect an indication ofeye movement, and storing a set of electroencephalogram (EEG) electrodesconfigured to detect an indication of electrical brain activity, and themethod of Example 11 includes providing instructions with the receptaclefor using the ECG electrodes, the set of bipolar surface EMG electrodes,the triple EMG chin electrode, the set of EOG electrodes, and the set ofEEG electrodes for sleep diagnostic testing.

In Example 19, the storing the single set of sleep-related sensors inthe receptacle of any Examples 1-18 includes storing the single set ofsleep-related sensors in a pouch.

In Example 20, the storing the single set of sleep-related sensors inthe receptacle of any of Examples 11-18 includes storing the single setof sleep related sensors in a compartmentalized tray.

While the present disclosure is directed toward treatment of sleepdisorders, further areas of applicability will become apparent from thedescription provided herein. It should be understood that thedescription and specific examples are intended for purposes ofillustration only and are not intended to limit the scope of the presentdisclosure.

DESCRIPTION OF THE DRAWINGS

The forgoing features, objects and advantages of the invention willbecome apparent to those skilled in the art from the following detaileddescription, especially when considered in conjunction with theaccompanying drawings in which like the numerals in the several viewsrefer to the corresponding parts:

FIG. 1 illustrates generally an example of a Type I sensor kit for sleepdiagnostic testing.

FIG. 2 illustrates generally an example of a Type II sensor kit forsleep diagnostic testing.

FIG. 3 illustrates generally an example of a Type III sensor kit forsleep diagnostic testing.

FIG. 4 illustrates generally an example of a Type IV sensor kit forsleep diagnostic testing.

FIGS. 5A-D illustrate generally an example of a Type I & Type II sensorkit tray for sleep diagnostic testing.

FIGS. 6A-D illustrate generally an example of a Type III & Type IVsensor kit tray for sleep diagnostic testing.

DETAILED DESCRIPTION

The following detailed description relates to a sensor kit for sleepdiagnostic testing. Each identified sensor kit is designed for sleepdiagnostic testing directed toward treating patients with sleepdisorders. The sleep sensors are adapted to be attached to patientsduring sleep studies in order to diagnose undesired sleep behavior orconditions obstructive sleep apnea, central sleep apnea, complex sleepapnea, snoring, restless leg syndrome (RLS), periodic limb movement(PLM), bruxism (teeth grinding and clenching), sudden infant deathsyndrome (SIDS) and other neurological disorders not necessarily relatedto sleep. The sensors transmit biomedical data to various types andlevels of PSG machines.

The following detailed description includes discussion of theconfiguration of the sensor kit for sleep diagnostic testing.Additionally, molded trays containing the various sensor kits for amultitude of sleep diagnostic configurations are also included.

FIG. 1 illustrates generally an example of a Type I sensor kit for sleepdiagnostic testing. Included are a thoracic (chest) effort belt 102, anabdominal effort belt 104, an oxygen saturation sensor 106, a nasal andoral airflow sensor 108, ECG electrodes 110, bipolar surface EMGelectrodes 112, a triple EMG chin electrode 114, three EOG/groundelectrodes 116, ten EEG electrodes 118 and one neck snore sensor 120.

The chest effort belt 102 and abdominal effort belt 104 are each bodyencircling bands having PVDF film transducers suitably mounted thereonso as to respond to stretching and relaxation of the belt due to therise and fall of the chest and abdomen due to respiratory activity. Theoxygen saturation sensor 106 is typically a finger clip having a set ofinfrared sources and sensors mounted thereon and adapted to be connectedto a pulse oximeter by a cable. The nasal and oral air flow sensor 108preferably comprises a PVDF film transducer sandwiched between layers offlexible plastic and having an adhesive thereon for adhering thetransducer on the upper lip. A length of wire is used to connect thetransducer element to a PSG machine. The ECG electrodes comprise any ofa number of commercially available skin contacting electrodes that areadapted to snap on to leads (not shown) that connect to the ECG machine.

The EMG chin electrodes 114 are disposed on a flexible adhesivesubstrate that is adapted to adhere to the chin of a subject fordetecting vibrations that may be caused by teeth grinding during sleep.

The EOG electrodes 116 are adapted to be placed on or about thesubject's eye lids for sensing when the subject is in REM sleep mode.

The EEG electrodes 118, are commercially available and, as seen in FIG.1, include surface electrodes connected by cabling to electricalterminals that are connectable to the EEG electronics module.

The snore sensor 120 comprises a PVDF piezoelectric transducer that isconnectable by a length of cabling to the PSG electronics module and, inuse, produces a signal indicative of throat vibrations present duringepisodes of snoring.

FIG. 2 illustrates generally an example of a Type II sensor kit forsleep diagnostic testing including a thoracic (chest) effort belt 102,an abdominal effort belt 104, an oxygen saturation sensor 106, a nasaland oral airflow sensor 108, ECG electrodes 110, a bipolar surface EMGelectrode 112, a triple EMG chin electrode 114, and three EOG/groundelectrodes 116.

FIG. 3 illustrates generally an example of a Type III sensor kit forsleep diagnostic testing including a thoracic (chest) effort belt 102,an abdominal effort belt 104, an oxygen saturation sensor 106, a nasaland oral airflow sensor 108 and ECG electrodes 110.

FIG. 4 illustrates generally an example of a Type IV sensor kit forsleep diagnostic testing including a thoracic (chest) effort belt 102,an abdominal effort belt 104, an oxygen saturation sensor 106 and anasal and oral airflow sensor 108.

In an example, the nasal and oral airflow sensor 108 in FIG. 1 through 4is a piezoelectric sensor constructed in accordance with the teachingsof U.S. Pat. No. 5,311,875, U.S. Pat. No. 6,254,545, U.S. Pat. No.6,485,432, U.S. Pat. No. 6,491,642, U.S. published application no.2007/0012089 and U.S. Provisional Patent Application Ser. No. 61/075,136filed Jun. 24, 2008 to Stasz and U.S. Pat. No. 6,894,427 to Alfini, theteachings of which are hereby incorporated by reference as if fully setforth herein.

In various embodiments, the effort belts 102 and 104 in FIG. 1 through 4are effort belts in accordance with the teachings of U.S. applicationSer. No. 11/743,389 filed May 3, 2007, the teachings of which are herebyincorporated by reference as if fully set forth herein.

FIGS. 5A-D illustrate generally an example front view 122, side view126, rear view 124 and isometric view 126 of a Type I & Type II sensorkit tray. The tray is preferably formed in a suitable thermal formingprocess from a suitable medical grade thermoplastic to create aplurality of divided compartments designed to segregate and store theseveral types of disposable sensors/electrodes during shipping andhandling prior to uncovering at the time of use.

FIGS. 6A-D illustrate generally an example front view 130, side view132, rear view 134 and isometric view 136 of a Type III & Type IV sensorkit tray. The trays shown in FIGS. 5A-D and 6A-D are illustrative onlyand may comprise greater or fewer numbers of compartments.

Those skilled in the art will understand and appreciate that varioussleep diagnostic sensors include, but are not limited to, thermocouples,thermistors, piezo and pyroelectric transducers, air pressuretransducers, electrodes, respiratory inductance plethysmography andrespiratory effort plethysmography belts.

The systems or method incorporated herein are advantageous because it isdirected toward the clean, safe, and practical use and application ofall required sleep diagnostic sensors and/or electrodes in a single kit.

Additional advantages include time savings or convenience of having onepre-arranged sleep sensor kit containing all required sleep sensors forvarying out the prescribed sleep diagnostic testing, which can provide aclean, safe, practical and convenient way to perform sleep diagnostictesting in either the sleep laboratory or home environment.

The present subject matter has been described herein in considerabledetail to comply with the patent statutes and to provide those skilledin the art with the information needed to apply the novel principles andto construct and use such specialized components as are required.However, it is to be understood that the present subject matter can becarried out by specifically different equipment and devices, and thatvarious modifications, both as to the equipment and operatingprocedures, can be accomplished without departing from the scope of thepresent subject matter.

The description of the various embodiments is merely exemplary in natureand, thus, variations that do not depart from the gist of the examplesand detailed description herein are intended to be within the scope ofthe present disclosure. Such variations are not to be regarded as adeparture from the spirit and scope of the present disclosure.

1. A system for storing pre-packaged sleep related sensors andfacilitating effective, efficient, or error-free usage of the sleeprelated sensors for sleep diagnostic testing, the system comprising: areceptacle configured to store sleep related sensors; and a single setof sleep-related sensors, comprising: a thoracic respiratory effort beltconfigured to detect chest movement indicative of respiratory effort; anabdominal respiratory effort belt configured to detect abdominalmovement indicative of respiratory effort; an oxygen saturation sensorconfigured to an indication of blood oxygen saturation; and a nasal andoral airflow sensor configured to detect nasal and oral air flowinformation; wherein the receptacle includes instructions for using thethoracic respiratory effort belt, the abdominal effort belt, the oxygensaturation sensor, and the nasal and oral airflow sensor for sleepdiagnostic testing.
 2. The system of claim 1, wherein the single set ofsleep-related sensors includes a set of electrocardiogram (ECG)electrodes configured to sense electrical signals indicative of cardiacactivity, and wherein the receptacle includes instructions for using theset of ECG electrodes for sleep diagnostic testing.
 3. The system ofclaim 2, wherein the single set of sleep-related sensors include: a setof electrocardiogram (ECG) electrodes configured to sense electricalsignals indicative of cardiac activity; a set of bipolar surfaceelectromyogram (EMG) electrodes configured to detect an indication ofelectrical activity of a muscle; and a triple EMG chin electrodeconfigured to detect an indication of electrical activity at or near achin; wherein the receptacle includes instructions for using the set ofEMG electrodes, the triple EMG chin electrode, and the set of EOGelectrodes for sleep diagnostic testing.
 4. The system of claim 3,wherein the single set of sleep-related sensors includes a set ofelectroencephalogram (EEG) electrodes, and wherein the receptacleincludes instructions for using the set of EEG electrodes for sleepdiagnostic testing.
 5. The system of claim 1, wherein the single set ofsleep-related sensors consists of: the thoracic respiratory effort beltconfigured to detect chest movement indicative of respiratory effort;the abdominal respiratory effort belt configured to detect abdominalmovement indicative of respiratory effort; the oxygen saturation sensorconfigured to an indication of blood oxygen saturation; and the nasaland oral airflow sensor configured to detect nasal and oral air flowinformation;
 6. The system of claim 1, wherein the single set ofsleep-related sensors consists of the thoracic respiratory effort beltconfigured to detect chest movement indicative of respiratory effort;the abdominal respiratory effort belt configured to detect abdominalmovement indicative of respiratory effort; the oxygen saturation sensorconfigured to an indication of blood oxygen saturation; the nasal andoral airflow sensor configured to detect nasal and oral air flowinformation; and a set of electrocardiogram (ECG) electrodes configuredto sense electrical signals indicative of cardiac activity; and whereinthe receptacle includes instructions for using the set of ECG electrodesfor sleep diagnostic testing.
 7. The system of claim 1, wherein thesingle set of sleep-related sensors consists of: the thoracicrespiratory effort belt configured to detect chest movement indicativeof respiratory effort; the abdominal respiratory effort belt configuredto detect abdominal movement indicative of respiratory effort; theoxygen saturation sensor configured to an indication of blood oxygensaturation; the nasal and oral airflow sensor configured to detect nasaland oral air flow information; a set of electrocardiogram (ECG)electrodes configured to sense electrical signals indicative of cardiacactivity; a set of bipolar surface electromyogram (EMG) electrodesconfigured to detect an indication of electrical activity of a muscle; atriple EMG chin electrode configured to detect an indication ofelectrical activity at or near a chin; and a set of electrooculogram(EOG) electrodes configured to detect an indication of eye movement; andwherein the receptacle includes instructions for using the set of ECGelectrodes configured to detect an indication of electrical brainactivity, the set of EMG electrodes, the triple EMG chin electrode, andthe set of EOG electrodes for sleep diagnostic testing.
 8. The system ofclaim 1, wherein the single set of sleep-related sensors consists of:the thoracic respiratory effort belt configured to detect chest movementindicative of respiratory effort; the abdominal respiratory effort beltconfigured to detect abdominal movement indicative of respiratoryeffort; the oxygen saturation sensor configured to an indication ofblood oxygen saturation; the nasal and oral airflow sensor configured todetect nasal and oral air flow information; a set of electrocardiogram(ECG) electrodes configured to sense electrical signals indicative ofcardiac activity; a set of bipolar surface electromyogram (EMG)electrodes configured to detect an indication of electrical activity ofa muscle; a triple EMG chin electrode configured to detect an indicationof electrical activity at or near a chin; a set of electrooculogram(EOG) electrodes configured to detect an indication of eye movement; anda set of electroencephalogram (EEG) electrodes configured to detect anindication of electrical brain activity; and wherein the receptacleincludes instructions for using the set of ECG electrodes, the set ofEMG electrodes, the triple EMG chin electrode, the set of EOGelectrodes, and the set of electroencephalogram (EEG) electrodes forsleep diagnostic testing.
 9. The system of claim 1, wherein thereceptacle includes a pouch.
 10. The system of claim 1, wherein thereceptacle includes a compartmentalized tray.
 11. A method for storingpre-packaged sleep related sensors to facilitate effective, efficient,or error-free usage of the sleep related sensors for sleep diagnostictesting, the method comprising: storing a single set of sleep-relatedsensors in a receptacle, wherein storing the single set of sleep-relatedsensors comprises: storing a thoracic respiratory effort belt configuredto detect chest movement indicative of respiratory effort; storing anabdominal respiratory effort belt configured to detect abdominalmovement indicative of respiratory effort; storing an oxygen saturationsensor configured to an indication of blood oxygen saturation; andstoring a nasal and oral airflow sensor configured to detect nasal andoral air flow information; and providing instructions with thereceptacle for using the thoracic respiratory effort belt, the abdominalrespiratory effort belt, the oxygen saturation sensor, and the nasal andoral airflow sensor.
 12. The method of claim 11, wherein the storing thesingle set of sleep-related sensors in the receptacle comprises storinga set of electrocardiogram (ECG) electrodes configured to detect anindication of cardiac activity; and wherein the method includesproviding instructions with the receptacle for using the ECG electrodesfor sleep diagnostic testing.
 13. The method of claim 12, wherein thestoring the single set of sleep-related sensors in the receptacleincludes: storing a set of bipolar surface electromyogram (EMG)electrodes configured to detect an indication of electrical activity ofa muscle; storing a triple EMG chin electrode configured to detect anindication of electrical activity at or near a chin; and storing a setof electrooculogram (EOG) electrodes configured to detect an indicationof eye movement; and wherein the method includes providing instructionswith the receptacle for using the set of bipolar surface EMG electrodes,the triple EMG chin electrode, and the set of EOG electrodes for sleepdiagnostic testing.
 14. The method of claim 13, wherein the storing thesingle set of sleep-related sensors in the receptacle includes storing aset of electroencephalogram (EEG) electrodes configured to detect anindication of electrical brain activity; and wherein the method includesproviding instructions for using the set of EEG electrodes for sleepdiagnostic testing.
 15. The method of claim 11, wherein the storing thesingle set of sleep-related sensors in the receptacle consists of:storing the thoracic respiratory effort belt configured to detect chestmovement indicative of respiratory effort; storing the abdominalrespiratory effort belt configured to detect abdominal movementindicative of respiratory effort; storing the oxygen saturation sensorconfigured to an indication of blood oxygen saturation; and storing thenasal and oral airflow sensor configured to detect nasal and oral airflow information.
 16. The method of claim 11, wherein the storing thesingle set of sleep-related sensors in the receptacle consists of:storing the thoracic respiratory effort belt configured to detect chestmovement indicative of respiratory effort; storing the abdominalrespiratory effort belt configured to detect abdominal movementindicative of respiratory effort; storing the oxygen saturation sensorconfigured to an indication of blood oxygen saturation; storing thenasal and oral airflow sensor configured to detect nasal and oral airflow information; and storing a set of ECG electrodes configured todetect an indication of cardiac activity; and wherein the methodincludes providing instructions with the receptacle for using the ECGelectrodes for sleep diagnostic testing.
 17. The method of claim 11,wherein the storing the single set of sleep-related sensors in thereceptacle consists of: storing the thoracic respiratory effort beltconfigured to detect chest movement indicative of respiratory effort;storing the abdominal respiratory effort belt configured to detectabdominal movement indicative of respiratory effort; storing the oxygensaturation sensor configured to an indication of blood oxygensaturation; storing the nasal and oral airflow sensor configured todetect nasal and oral air flow information; storing a set ofelectrocardiogram (ECG) electrodes configured to detect an indication ofcardiac activity; storing a set of bipolar surface electromyogram (EMG)electrodes configured to detect an indication of electrical activity ofa muscle; storing a triple EMG chin electrode configured to detect anindication of electrical activity at or near a chin; and storing a setof electrooculogram (EOG) electrodes configured to detect an indicationof eye movement; and wherein the method includes providing instructionswith the receptacle for using the ECG electrodes, the set of bipolarsurface EMG electrodes, the triple EMG chin electrode, and the set ofEOG electrodes for sleep diagnostic testing.
 18. The method of claim 11,wherein the storing the single set of sleep-related sensors in thereceptacle consists of: storing the thoracic respiratory effort beltconfigured to detect chest movement indicative of respiratory effort;storing the abdominal respiratory effort belt configured to detectabdominal movement indicative of respiratory effort; storing the oxygensaturation sensor configured to an indication of blood oxygensaturation; storing the nasal and oral airflow sensor configured todetect nasal and oral air flow information; storing a set ofelectrocardiogram (ECG) electrodes configured to detect an indication of1 cardiac activity; storing a set of bipolar surface electromyogram(EMG) electrodes configured to detect an indication of electricalactivity of a muscle; storing a triple EMG chin electrode configured todetect an indication of electrical activity at or near a chin; storing aset of electrooculogram (EOG) electrodes configured to detect anindication of eye movement; and storing a set of electroencephalogram(EEG) electrodes configured to detect an indication of electrical brainactivity; and wherein the method includes providing instructions withthe receptacle for using the ECG electrodes, the set of bipolar surfaceEMG electrodes, the triple EMG chin electrode, the set of EOGelectrodes, and the set of EEG electrodes for sleep diagnostic testing.19. The method of claim 11, wherein the storing the single set ofsleep-related sensors in the receptacle includes storing the single setof sleep-related sensors in a pouch.
 20. The method of claim 11, whereinthe storing the single set of sleep-related sensors in the receptacleincludes storing the single set of sleep related sensors in acompartmentalized tray.